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Cervical Collar Device for Thyroid Disorders

N/A
Recruiting
Led By Prasanna Santhanam, MBBS, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Patients with diseases involving cervical spine, such as spondylosis and severe degenerative joint disease.
Pregnant Women, elderly and persons unable to understand simple instructions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9-12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a device that is worn around the neck and measures radioiodine exposure to help estimate the amount of iodine-131 that a person needs for treatment of thyroid disorders while minimizing risks of comorbidities.

Who is the study for?
This trial is for English-speaking individuals with Graves' disease confirmed by lab tests or those with intermediate/high-risk thyroid cancer needing radioiodine treatment. It's not suitable for pregnant women, the elderly, or anyone with certain cervical spine diseases.
What is being tested?
The study is testing a neck collar device called CoTI that measures radiation exposure from radioiodine treatments in real-time. This could lead to more accurate doses of radioactive iodine and reduce clinic visits compared to current methods.
What are the potential side effects?
While specific side effects are not listed, participants may experience discomfort wearing the CoTI device around their necks. The survey will assess patient experiences including any inconvenience or discomfort.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a condition affecting my neck's bones, like arthritis or wear and tear.
Select...
I am not pregnant, elderly, or unable to understand simple instructions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9-12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9-12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluation of the Variability in radioiodine kinetics for patients with thyroid cancer and graves disease
Secondary study objectives
Validation of the device as an enhancement of quantitative measurements in patients with Graves disease and thyroid cancer

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pilot ProjectExperimental Treatment1 Intervention
It is a Pilot study of 10 persons

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,756 Total Patients Enrolled
Prasanna Santhanam, MBBS, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Pilot Project Clinical Trial Eligibility Overview. Trial Name: NCT03517579 — N/A
Graves Disease Research Study Groups: Pilot Project
Graves Disease Clinical Trial 2023: Pilot Project Highlights & Side Effects. Trial Name: NCT03517579 — N/A
Pilot Project 2023 Treatment Timeline for Medical Study. Trial Name: NCT03517579 — N/A
~2 spots leftby Oct 2026
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